ClinicalTrials.gg
RecruitingNCT07936279Updated Nov 13, 2026

Geriatric Hip Fracture mFI-5 for Postoperative ICU Need and 30 Day Mortality

An observational study in Hip, Fractures and Frailty, sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 65 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
65 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 21 studies in Fractures, Bone with a site in Turkey — 3 open to participants now, 3 under way, none of them phase 3. Fractures, Bone · Turkey.

Started
2026
the only one that year
Observational
8 of 21
2 open now
Registered
21st of 21
by date
Lead sponsor
1 of 21
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Among the 21 studies in Fractures, Bone with a site in Turkey, this one is the only one that started in 2026, is one of 8 observational ones, and was the 21st registered.

Fractures, Bone

725 studies on the registry are indexed under Fractures, Bone; 116 are open to participants now.

Browse Fractures, Bone studies →

Open to participants now

3 of the 21 studies in Fractures, Bone with a site in Turkey are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 72 Fractures, Bone studies recruiting now, 36 (50%) set no upper age limit and 22 (31%) stop at 75 or younger; 17 take children under 18; 14 take healthy volunteers.

This study: 65 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies in Fractures, Bone with a site in Turkey, or all of them as a file.
02

Study summary

This prospective, observational, single-center study aims to evaluate the predictive value of the Modified Frailty Index-5 (mFI-5) score on postoperative intensive care unit (ICU) admission requirements and 30-day mortality in geriatric patients undergoing hip fracture surgery. Patients aged 65 and older presenting with a hip fracture will be evaluated preoperatively using the mFI-5 scoring system (assessing diabetes, hypertension, COPD, congestive heart failure, and functional dependence). Intraoperative hemodynamic data, anesthesia type, and transfusion requirements will be documented. Postoperative ICU admission, total hospital stay, and 30-day survival status will be recorded to assess the prognostic capability of preoperative frailty levels.

Read the detailed description

This single-center, prospective, observational study will be conducted at the Department of Anesthesiology and Reanimation of Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, following approval from the Institutional Ethics Committee. The primary objective is to evaluate the predictive value of the preoperative Modified Frailty Index-5 (mFI-5) score on postoperative intensive care unit (ICU) admission requirements and 30-day mortality in geriatric patients undergoing hip fracture surgery.

STUDY TIMELINE AND POPULATION Patient enrollment will take place between June 1, 2026, and January 1, 2027. All patients aged 65 years and older who present to the operating theater with a diagnosis of hip fracture (including femoral neck, intertrochanteric, or subtrochanteric fractures) and are scheduled for surgical treatment will be screened. Written informed consent will be obtained from all eligible patients or their legally authorized representatives in the preoperative period before any study-related procedures are initiated.

PREOPERATIVE ASSESSMENT (FRAILTY EVALUATION)

Prior to being transferred to the operating room, patients will be evaluated in the anesthesia outpatient clinic or the preoperative preparation holding area by a designated investigator. Frailty status will be determined using the Modified Frailty Index-5 (mFI-5), which consists of five distinct clinical criteria based on the patient's medical history:

  1. Presence of diabetes mellitus (regardless of insulin dependence).
  2. Presence of hypertension (requiring pharmacological treatment).
  3. History of Chronic Obstructive Pulmonary Disease (COPD).
  4. History of Congestive Heart Failure (CHF).
  5. Functional dependence status (defined as the need for assistance in performing activities of daily living within the last 30 days).

Each positive criterion will be scored as 1 point, yielding a total cumulative mFI-5 score ranging from 0 (robust/non-frail) to 5 (severely frail).

INTRAOPERATIVE MANAGEMENT AND MONITORING Upon arrival in the operating theater, standard American Society of Anesthesiologists (ASA) monitoring will be established for all patients, including electrocardiography (ECG), peripheral oxygen saturation (SpO2), and non-invasive blood pressure (NIBP). The choice of anesthesia method (general or regional anesthesia) will be decided by the primary attending anesthesia team based on patient comorbidities and clinical indications, and the type of anesthesia will be recorded.

Hemodynamic parameters, specifically systolic blood pressure, diastolic blood pressure, and heart rate, will be documented at 5-minute intervals throughout the operation. Intraoperative hypotension is strictly defined as a decrease of 20% or more from the patient's baseline blood pressure value. Episodes of hypotension will be managed according to standard clinical protocols using intravenous fluid resuscitation and/or vasopressors (e.g., ephedrine). Total intraoperative blood loss and the volume of blood products transfused will also be carefully quantified and recorded.

POSTOPERATIVE FOLLOW-UP AND OUTCOME MEASURES At the conclusion of the surgical procedure, the patient's requirement for intensive care unit (ICU) admission will be evaluated. Postoperative ICU admission will be determined based on standardized institutional clinical protocols, including the presence of hemodynamic instability, the need for mechanical ventilatory support, or the requirement for close invasive monitoring.

Following surgery, patients will be monitored through hospital discharge to determine the total length of hospital stay (measured in days). The primary definitive endpoints-survival status and the 30-day mortality rate-will be evaluated precisely 30 days after the operation. This long-term follow-up data will be retrieved directly from the national electronic hospital information system registries or via structured telephone interviews conducted with the patients or their primary caregivers. All collected variables will be documented in a dedicated case report form for final statistical modeling.

03

Conditions studied

  • Hip
  • Fractures
  • Frailty
  • Aged

Keywords

  • mFI-5
  • Modified Frailty Index
  • Geriatric Hip Fracture
  • ICU Admission
  • 30-Day Mortality
  • Preoperative Risk Assessment
  • Predictive Value
04

Who can participate

Ages eligible
65 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of geriatric patients aged 65 years and older who present to the emergency department or orthopedic clinics of a tertiary training and research hospital and are subsequently admitted to the operating theater for hip fracture surgery.

The cohort will encompass all consecutive eligible patients scheduled for surgical repair of a femoral neck, intertrochanteric, or subtrochanteric fracture under general or regional anesthesia between June 1, 2026, and January 1, 2027.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients aged 65 years and older. Diagnosed with a hip fracture (including femoral neck, intertrochanteric, or subtrochanteric fractures).

Scheduled to undergo surgical treatment for the hip fracture. Anesthesia management planned under general or regional (spinal/epidural) anesthesia.

(ASA) physical status classification I, II, III, or IV.

Written provided voluntarily by the patient or their legally authorized representative prior to surgery.

Exclusion criteria

Exclusion Criteria:

Patients under 65 years of age. Presence of high-energy injuries, major head trauma, or multiple trauma (polytrauma).

Patients who are intubated or require mechanical ventilation in the preoperative period.

Pathological fractures secondary to primary bone or bone (if applicable per protocol).

Refusal to undergo surgery or failure/refusal to provide written .

Patients with missing 30-day postoperative follow-up data or incomplete medical records.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Geriatric Hip Fracture Patients

    Geriatric patients aged 65 years and older who undergo surgical treatment for hip fracture (femoral neck, intertrochanteric, or subtrochanteric fractures) under general or regional anesthesia. All enrolled patients will be evaluated preoperatively using the Modified Frailty Index-5 (mFI-5) score and followed for 30 days postoperatively.

    Other: Preoperative mFI-5 Assessment and Standard Surgical/Anesthetic Care

Interventions

  • OtherPreoperative mFI-5 Assessment and Standard Surgical/Anesthetic Care

    Preoperative frailty assessment using the Modified Frailty Index-5 (mFI-5) in the preoperative period. Standard perioperative care, including general or regional anesthesia tailored to the patient's clinical indications, intraoperative hemodynamic monitoring (every 5 minutes), and standard postoperative follow-up for ICU admission and 30-day mortality.

06

What researchers measure

Primary outcomes

  1. Postoperative Intensive Care Unit (ICU) Admission Rate

    he percentage of patients requiring admission to the intensive care unit during the postoperative period based on standardized clinical protocols (e.g., hemodynamic instability, need for mechanical ventilatory support, or close invasive monitoring). The predictive accuracy and optimal cut-off value of the preoperative Modified Frailty Index-5 (mFI-5) score for this outcome will be determined using Receiver Operating Characteristic (ROC) curve analysis, calculating the Area Under the Curve (AUC), sensitivity, and specificity.

    Time frame: From the end of surgery up to 30 days postoperatively.

Secondary outcomes

  1. 30-Day Mortality Rate

    The total duration of hospitalization measured in days. The association between the preoperative mFI-5 frailty scores and the length of hospital stay will be analyzed to assess the impact of baseline frailty on resource utilization.

    Time frame: From the day of hospital admission for surgery until official hospital discharge (approximately 30 days).

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Chan SF, Connelly M, Wallace DP. The Relationship Between Pain Characteristics, Peer Difficulties, and Emotional Functioning Among Adolescents Seeking Treatment for Chronic Pain: A Test of Mediational Models. J Pediatr Psychol. 2017 Oct 1;42(9):941-951. doi: 10.1093/jpepsy/jsx074. PubMed 28431011 ↗
  • Tkachenko E, Singer S, Mostaghimi A, Hartman RI. Association of poor mental health and skin cancer development: a cross-sectional study of adults in the United States. Eur J Cancer Prev. 2020 Nov;29(6):520-522. doi: 10.1097/CEJ.0000000000000567. PubMed 31934914 ↗
  • Hofmann B, Gerull KA, Bloch K, Riemer M, Erbs C, Frohlich A, Richter S, Ehrhardt M, Zitterbart C, Bartel FF, Siegel P, Wienke A, Silber RE, Simm A. It's all in our skin-Skin autofluorescence-A promising outcome predictor in cardiac surgery: A single centre cohort study. PLoS One. 2020 Jun 29;15(6):e0234847. doi: 10.1371/journal.pone.0234847. eCollection 2020. PubMed 32598375 ↗

Individual participant data

Plan to share: No — Institutional review board restrictions and local data protection regulations (KVKK) prohibit the public sharing of individual participant data to ensure patient privacy. However, de-identified aggregate data and statistical analyses may be made available to qualified researchers upon reasonable collaborative request to the corresponding author.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for May 2027, 10 months after the start.

Of 67 non-industry observational studies under Fractures, Bone, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 88. This study's planned 10 months is below that.

Counting every sponsor, half of 87 studies reached it within 46 months; a quarter within 20 and three quarters within 124.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2026
First posted
Nov 13, 2026
StartActual
Jul 1, 2026
Primary completionEst.
May 5, 2027
CompletionEst.
Aug 5, 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07936279
Lead sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Responsible party
özge cihangir özek (MD, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital) — Principal investigator
First posted
Nov 13, 2026
Start date
Jul 1, 2026
Primary completion
May 5, 2027 (estimated)
Completion
Aug 5, 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Özge K Cihangir Özek, MD
Contact
ozgecigangirozek@hotmail.com
05064969856
Kamuran K KOÇYİĞİT ÖZER, MD
Contact
kkcygt@gmail.com
5322082920
Özge K Cihangir Özek, MD
principal investigator · Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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